A clinical trial (also referred to as an “interventional study”) generally corresponds to a series of tests for medical research and/or drug development that collects large amounts of data related to the medical research and/or drug development. After completion of a clinical trial, the data and findings may be compiled and a clinical study report is created that includes protocol, statistical analysis plan and locked data reports. Conventionally, the protocol, statistical analysis plan, and locked data reports may be manually analyzed and formatted into the International Conference on Harmonisations' (ICH) E3 Guidelines for the Structure of the Clinical Study report, and the formatted clinical study report may be provided to the appropriate governmental agency for submission. Manual formatting and review of a clinical study report requires a significant investment of resources, including for example approximately four months of time.
The United States National Institutes of Health maintains a database of publicly and privately supported clinical studies (accessible at http://www.clinicaltrials.gov) that indicates approximately 130,000 clinical trials are registered for the database. As such, the significant time delay and cost of formatting clinical studies for submission is an increasingly important problem.
Therefore, a significant need continues to exist in the art for improved systems and methods for the generation and review of formatted clinical study reports.